Nucleus 22 Cochlear Implant System
FDA premarket approval P890027/S061 · decided 2022-12-06
Approval details
- PMA number
- P890027
- Supplement
- S061
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Nucleus 22 Cochlear Implant System
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2022-09-07
- Decision date
- 2022-12-06
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for the Cochlear Nucleus® MRI Kit, an accessory, together with associated labeling changes, to allow certain Nucleus implant recipients to undergo MRI scans at 1.5 T with the implant magnet in place.
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